When orals attack: how to ensure product access

Therapeutic categories long dominated by IV-infused therapies face oral-product competition. Gilenya's launch into the IV-infused/self-injection dominated multiple sclerosis market is an example. In this scenario, manufacturers of the oral newcomers face some complexities:

• Will adherence rates be on par with IV-infused/self-injectable competitors?

• Is specialty or retail pharmacy the most appropriate distribution channel?

• How should the oral product be priced to effectively compete with injected therapies?

• Will co-pays or coinsurance be the mechanism most plans use to share costs with patients?

• What patient support services will be required?

• What office manager, nurse, and physician education specific to reimbursement and patient services will be necessary?

When oral-dominated therapeutic categories face IV-infused competition, manufacturers of the new infused therapies face different issues:

• Where will the IV-infused product most likely be administered—physician's office, standalone infusion center, hospital? How will these dynamics impact targeting and promotion?

• Do targeted MDs possess the capabilities to administer IV-infused products in the office? If not, what level of education is needed to ensure physicians understand the dynamics surrounding the product's use?

• What benefits will the new product possess over the oral agents that should be considered when establishing price?

• How will health plans manage the IV-infused therapy? Which stakeholders and processes are needed for advocacy, and what must be understood to ensure optimal reimbursement?

• What Medicare Carrier and Contractor Advisory Committee processes are important to understand to streamline reimbursement?

Many areas of the commercialization strategy and marketing mix are impacted, including distribution, contracts and pricing, health economics and outcomes research, HCP and consumer promotion, training, and site-of-care marketing. With the evolution of science and healthcare reform, remaining a step ahead of these paradigm shifts may prove the difference between leaders and followers.

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